510(k) clearances
Premarket notifications cleared by FDA, newest decision first.
Every 510(k) record MDM has ingested from openFDA. Each clearance page carries the record as FDA published it, the product code it was cleared under, recalls sharing that product code, and a link to the FDA source.
Data as of , the FDA export date. FDA 510(k) database
Clearances by decision year
Last 15 yearsShow the numbers
| Year | Clearances |
|---|---|
| 2012 | 3,135 |
| 2013 | 3,052 |
| 2014 | 3,202 |
| 2015 | 3,020 |
| 2016 | 2,956 |
| 2017 | 3,200 |
| 2018 | 3,062 |
| 2019 | 2,918 |
| 2020 | 2,923 |
| 2021 | 3,023 |
| 2022 | 3,209 |
| 2023 | 3,346 |
| 2024 | 3,129 |
| 2025 | 3,225 |
| 2026 | 2,502 |
| K number | Device | Applicant | Product code | Class | Decision date |
|---|---|---|---|---|---|
| K240886 | Fluent Pro Fluid Management System (FLT-200); Fluent Pro Fluid Management System Disposable Procedure Kit (6-pack) (FLT-212); Fluent Pro Fluid Management System Disposable Procedure Kit (1-pack) (FLT-212S); Fluent Pro Fluid Management System Tissue Trap Multipack (10-pack) (FLT-210); Fluent Pro Fluid Management System Waste Bag Multipack (5-pack) (FLT-205) | Hologic, Inc. | HIG | Class II | |
| K233563 | Navident | ClaroNav Inc. | PLV | Class II | |
| K233372 | KARL STORZ Fiber Telescopes for Urology | Karl Storz SE & Co. KG | FGB | Class II | |
| K241863 | Erisma® Lp Spinal Fixation System; Erisma® LP MIS | Clariance, Inc. | NKB | Class II | |
| K241789 | Non-Sterile Ultrasound Transmission Gels | Hony Medical Co., Ltd | MUI | Class II | |
| K241502 | P-Scope | Oui Medical, Inc. | GCJ | Class II | |
| K241243 | Intra-Operative Positioning System (IOPS®) Viewpoint (Simple Curve Catheters); Intra-Operative Positioning System (IOPS®) Viewpoint (Double Curve Catheters) | Centerline Biomedical | DQK | Class II | |
| K241150 | MISTI Silicone Implant | Keosan Trading Co. | MIB | Class II | |
| K241130 | “POINT” Kinguide Agile Hybrid Navigation System (PSHF01-000) | Point Robotics MedTech Inc. | OLO | Class II | |
| K240780 | InMode RF System | Inmode Ltd. | GEI | Class II | |
| K240714 | Insure® Universal; Insure® Universal Automix | Cosmedent, Inc. | EMA | Class II | |
| K240457 | C2 CryoBalloon Ablation System (C2 CryoBalloon Ablation System) | PENTAX of America, Inc. | GEH | Class II | |
| K240431 | ExacTrac Dynamic (2.0); ExacTrac Dynamic Surface | Brainlab, Inc. | IYE | Class II | |
| K240044 | Caddie | Odin Medical Limited | QNP | Class II | |
| K233865 | X-Smart Pro; X-Smart Pro+ | Dentsply Sirona Inc | EKX | Class I | |
| K233352 | Aptima HCV Quant Dx Assay | Hologic, Inc. | MZP | Class II | |
| K231251 | FlexWing Anterior Cervical Plate System | Jeil Medical Corporation | KWQ | Class II | |
| K230305 | THE Graft Collagen | Purgo Biologics Inc. | NPM | Class II | |
| K241296 | Gaudi Proximal Humerus Plate | Netbiologics LLC | HRS | Class II | |
| K241114 | EzDent-i / E2 / Prora View / Smart M Viewer (v3.5) | Ewoosoft Co., Ltd | LLZ | Class II | |
| K240906 | TE Air Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co.,LTD | IYN | Class II | |
| K240756 | Aitrics-Vc | Aitrics Co., Ltd. | PLB | Class II | |
| K241482 | Kinos Total Ankle System | restor3d, Inc. | HSN | Class II | |
| K241445 | K-Bond Universal | Spident Co., Ltd. | KLE | Class II | |
| K241119 | Transcutaneous Electrical Nerve Stimulator (K6106) | Shenzhen Yicai Health Technology Co., Ltd | NUH | Class II | |
| K241116 | Onycho Laser V | Terasysd&C, Inc. | PDZ | Class II | |
| K240704 | ACUSON Sequoia Diagnostic Ultrasound System, ACUSON Sequoia Select Diagnostic Ultrasound System, ACUSON Origin Diagnostic Ultrasound System, ACUSON Origin ICE Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | IYN | Class II | |
| K240558 | Navoycds | Algodx AB | PLB | Class II | |
| K240339 | Electric Wheelchair (Robooter E60) (BBR-E60-01); Electric Wheelchair (Robooter E60) (BBR-E60-02); Electric Wheelchair (Robooter E60) (BBR-E60-03); Electric Wheelchair (Robooter E60) (BBR-E60-04); Electric Wheelchair (Robooter E60) (BBR-E60-05); Electric Wheelchair (Robooter E60) (BBR-E60-06); Electric Wheelchair (Robooter E60) (BBR-E60-07); Electric Wheelchair (Robooter E60) (BBR-E60-08) | Shanghai Bangbang Robotics Co., Ltd. | ITI | Class II | |
| K234091 | Maverick Diagnostic System TC1000; Maverick Test Panel A0.B0 | Genalyte, Inc. | JLW | Class II | |
| K231133 | neo315 | Neoscan Solution GmbH | LNH | Class II | |
| K240347 | Ptg-05 | Zimmer Medizinsysteme GmbH | NGX | Class II | |
| K241809 | coactiv+™ Antimicrobial Wound Gel | Kane Biotech Inc | FRO | Unclassified | |
| K240835 | Suture Button Repair System | Skeletal Dynamics, Inc | MBI | Class II | |
| K240538 | Premium Teeth Resin | Formlabs Ohio, Inc. | EBG | Class II | |
| K240480 | IntelliBlate Microwave Ablation System Console (IB-CON); IntelliBlate Microwave Ablation System Mobile Cart (IB-CART); IntelliBlate Ximitry Probe Assembly, 13G x 15cm (IB-XPA-1315); IntelliBlate Ximitry Probe Assembly, 13G x 20cm (IB-XPA-1320); IntelliBlate Ximitry Probe Assembly, 13G x 27cm (IB-XPA-1327) | Varian Medical Systems, Inc. | NEY | Class II | |
| K233979 | VACUETTE® QUICKSHIELD Complete (Plus) | Greiner Bio-One North America, Inc. | JKA | Class II | |
| K233976 | VasoGuard (V10, V8, V6, V4, V2) | Corvascular Diagnostics, LLC | JOP | Class II | |
| K233866 | Senhance Surgical System | Asensus Surgical, Inc. | NAY | Class II | |
| K233067 | Wireless TENS & EMS (Model SM9110,SM9113,SM9116) | Chongqing Rob Linka Science and Technology Co., Ltd. | NUH | Class II | |
| K241879 | vRad Viewer | Virtual Radiologic Corporation | LLZ | Class II | |
| K241463 | Electric Wheelchair (MP201C); Electric Wheelchair (MP201L) | Suzhou Master Machinery Manufacturing Co.,Ltd. | ITI | Class II | |
| K241321 | Juliet® Ti LL Lumbar Interbody Device | Spineart SA | OVD | Class II | |
| K241240 | Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay | Hologic, Inc. | QOF | Class II | |
| K241206 | Quantum Perfusion Hybrid System | Spectrum Medical Inc | DTN | Class II | |
| K241060 | HardyDisk AST Cefiderocol 30µg (FDC30) | Hardy Diagnostics | JTN | Class II | |
| K240821 | B4C System - Addition of new sensor model (BcSs-PICNIW-2000) | Braincare Desenvolvimento e Inovacao Tecnologica S.A. | GWM | Class II | |
| K240340 | Surgical Drive System (Model: ES70, ES90, E8) | Guangdong Jinme Medical Technology Co., Ltd. | DZI | Class II | |
| K234029 | CEFALY Connected - OTC, CEFALY Connected - Rx | Cefaly Technology | PCC | Class II | |
| K233917 | ICHOR 7F Embolectomy System (ICH-7F) | Ichor | QEW | Class II |